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Pfizer's Arthritis Drug Wins European Approval In Pediatric & Adult Patients
Monday, August 23, 2021 - 8:25am | 215The European Commission (EC) has approved Pfizer Inc's (NYSE: PFE) Xeljanz (tofacitinib) for active polyarticular juvenile idiopathic arthritis (JIA) and juvenile psoriatic arthritis (PsA). The approval covers two years of age and older patients who did not respond to...
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After FDA Rejection, EMA Approves FibroGen-Astellas' Roxadustat
Friday, August 20, 2021 - 9:19am | 312The European Commission (EC) has approved FibroGen Inc (NASDAQ: FGEN) and Astellas Pharma's (OTC: ALPMF) Evrenzo (roxadustat) for anemia caused by chronic kidney disease (CKD), just days after the FDA turned down the drug. Related: FDA Shoots Down Roxadustat...
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Bristol Myers Wins Positive Opinion From EU For Opdivo/Yervoy Combo In Colorectal Cancer
Monday, May 24, 2021 - 8:21am | 148The European Medicines Agency's advisory group CHMP has adopted a positive opinion recommending approval of Bristol Myers Squibb & Co's (NYSE: BMY) Opdivo (nivolumab) in combination with Yervoy (ipilimumab), a subset of metastatic colorectal cancer (mCRC). The...
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Abbott's Upgraded TriClip Heart Valve System OK'd In Europe
Thursday, April 8, 2021 - 1:38pm | 284Abbott Laboratories (NYSE: ABT) won European approval for the latest generation of its TriClip system, a transcatheter-based repair device designed to stem leaks in the heart’s tricuspid valve. The tricuspid valve opens and closes a set of three flaps rather than two....
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Deutsche Bank Maintains Buy on Biogen Idec After European Medical Agency Announcement
Friday, January 20, 2012 - 8:11am | 162Deutsche Bank has published a research report on Biogen Idec (NASDAQ: BIIB) after the European medical agency announced its risk/benefit review of multiple-sclerosis treatment Gilenya. In the report, Deutsche Bank writes, "The review is due to concerns related to reports of sudden deaths post...